Equivalence of Boosted Atazanavir Based Regimens and Currently Effective HAART Regimens

• Status: Completed
• Trial end date: 2016-11-23
• Target enrollment: 0
• Participant gender: All

Summary

The hypothesis for this study is whether a treatment regimen containing Atazanavir in combination with Ritonavir will work as well as other regimens containing a protease inhibitor and/or a Non-nucleoside Reverse Transcriptase Inhibitor (NNRTI) at controlling HIV disease in children who are HIV+ and have high cholesterol or high triglycerides. . In this study, children who have high cholesterol or high triglycerides as a result of their HIV medicines, will have the PI or NNRTI in their medication regimen changed to Atazanavir, which is a PI in combination with a low dose of Ritonavir (another PI). Atazanavir has been shown in adults to result in lower cholesterol and triglycerides than other PI's and NNRTI's. The dose of Atazanavir and Ritonavir will be according to the Package Insert for this drug that is FDA approved for children. They will continue taking the other medications from the pre-study regimen. Children will take study drug for 24 weeks, and will be able to continue study drug after the study using commercially available drug. Lab tests and a physical exam will be undertaken at 4 weeks, 12 weeks and 24 weeks after starting study drug to determine how effective the new drug is and to monitor for possible side effects.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Phoenix Children's Hospital
• Collaborator: Bristol-Myers Squibb
• Treatments: Atazanavir Sulfate

Criteria

Inclusion Criteria:

• HIV positive children with elevated lipid levels

• on stable HAART for at least 3 months (defined to be on the same regimen with viral load < 1000 for 6 months prior to baseline visit).

• Weight equal to or greater than 25kg

• Able to swallow pills or willing to learn

Exclusion Criteria:

• Patients with underlying hepatitis B or C viral infections

• Previously demonstrated clinically significant hypersensitivity (eg, Stevens-Johnson syndrome, erythema multiforme, or toxic skin eruptions) to any of the components of Reyataz® (atazanavir).

• Taking other medications that are highly dependent on CYP3A or UGT1A1 for clearance

• Ergot medicines: dihydroergotamine, ergonovine, ergotamine, and methylergonovine such as Cafergot®, Migranal®, D.H.E. 45®, ergotrate maleate, Methergine®, and others (used for migraine headaches).

• Orap® (pimozide, used for Tourette's disorder).

• Propulsid® (cisapride, used for certain stomach problems).

• Triazolam, also known as Halcion® (used for insomnia).

• Midazolam, also known as Versed® (used for sedation), when taken by mouth.

• Camptosar® (irinotecan, used for cancer).

• Crixivan® (indinavir, used for HIV infection).

• Cholesterol-lowering medicines Mevacor® (lovastatin) or Zocor® (simvastatin).

• Rifampin (also known as Rimactane®, Rifadin®, Rifater®, or Rifamate®).

• St. John's wort (Hypericum perforatum), an herbal product sold as a dietary supplement,

• Viramune® (nevirapine, used for HIV infection).

• Vfend® (voriconazole).

• Patients with grade 3 or higher elevations in transaminases (> 10 X ULN)

• Women of Childbearing Potential who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period.

• Women who are pregnant or breastfeeding.

• Women with a positive pregnancy test.